Pharmaceutical technologies are now in a phase of acceleration with regulatory authorities making the industry to take advantage of modern technologies. For several years, the pharmaceuticals industry has been conservative and too frightened to adopt new technologies because of regulatory inertia, according to Gordon J Farquharson, a part of WHO-ISO Committee and an expert in GMPs.
Talking to Pharmabiz, he said regulations framed by the US FDA, WHO and EU are based on the same principles of Good Manufacturing Practices (GMPs). Though the regulations are similar, the way they are 'policed' are different. Compliance with GMP, meeting legal obligations and undergoing inspections has become critical to pharma industry worldwide. GMPs are philosophies, not standards, he added.
Even the knowledge that GMP inspectors have across the world is also variable and sometimes inconsistent. Inspection problems may some times occur due to these variables. For instance, inspections done in one part of the Europe may be different from those carried out in other parts of the Europe.
Gordon who is an expert in the area of GMPs in clean rooms said, even after 30 years, many of the same problems are arising in the pharmaceutical industry in the area of clean rooms, both in the developing and developed countries. The major challenges to the industry had been the basic understanding of contamination techniques including air flow control, process control and air filtration.
Several advancements have been seen in the clean room technologies. Notable advancements are isolator, control and monitor technologies. Isolator technologies efficiently help in isolating people from processes. But this system does not suit all processes and products. Thus, still many rely on traditional clean room systems. The control and monitor technology is a sophisticated system for air volume control and monitoring temperature, humidity, pressure and particles.
On the new guidelines and revisions relating to clean rooms, Gordon informed, new guidelines concerning environmental control for sterile and non-sterile products are expected to be published during November 2006. Further, clean room guidelines (14644-1) are being revised and updated, which are likely to be published by end of 2008. EU-GMP Annex 1 is also being revised now and will be published by early 2007.
Talking about the GMP compliance in India, he said, part of the Indian pharma industry is more developed than part of the pharma industry in the Europe. Indian pharma companies should ensure that their practices are international and equal to best in class worldwide.
When asked about the recognition of Indian GMP in the US and Europe, he responded, mutual regulatory recognition is still a long way to go. There is no mutual recognition between the US and Europe, till date. One is still relying on overseas inspections. There is a difference in approach to GMPs worldwide. GMP in the US is law, while in other countries they are mere guidelines that support a high level law, he added.
Gordon has been involved in updating and improving the clean room classification and monitoring requirements in Annex 1 of the EU and PIC/S GMPs and has completed writing WHO's new Pharmaceutical water GMP Guidance.